NCCIH Natural Product Early Phase Clinical Trial Award (R33 Clinical Trial Required)
Open Posted
- Opportunity number
- PAR-25-270
- Agency
-
National Institutes of Health
Department of Health and Human Services
- Applications due
- Award size
- Up to $1,050,000
Opportunity facts
- Assistance listings
- Funding instrument
- Grant
- Category
-
- Health
- Eligible applicants
-
- Tribal Organizations (Not Federally Recognized)
- Higher Education Inst. (Private)
- City/Township Governments
- Small Businesses
- Non-501(c)(3) Nonprofits
- Higher Education Inst. (Public)
- State Governments
- 501(c)(3) Nonprofits
- For Profit Organizations
- Other
- Tribal Governments (Federally Recognized)
- County Governments
- Special District Governments
- Independent School Districts
- Public or Indian Housing Auth.
- Points of contact
-
- NIH OER Webmaster grantsinfo@nih.gov
- Full announcement
Opportunity details come from Grants.gov. Updated .
About this opportunity
The National Institutes of Health National Center for Complementary and Integrative Health seeks applicants for investigator-initiated, early-phase clinical trials of natural products with application due November 13, 2026, under the R33 Clinical Trial Required mechanism.
Eligible applicants include higher education institutions (public and private), 501(c)(3) and non-501(c)(3) nonprofits, small businesses, for-profit organizations, state and local governments, tribal governments (federally and non-federally recognized), and other entities including faith-based organizations, historically black colleges and universities, Hispanic-serving institutions, and tribally controlled colleges and universities. Non-domestic entities and non-domestic components of U.S. organizations are ineligible.
This funding mechanism supports up to three years of investigator-initiated research on botanicals, dietary supplements, probiotics, and standardized nutritional regimens that have compelling preliminary evidence. Trials must be hypothesis-driven, milestone-driven, and directly related to NCCIH's mission and research priorities. Applicants must design studies to replicate the natural product's impact on target engagement in humans and assess associations between the degree of target engagement and functional or clinical outcomes in patient populations. Applications are encouraged to optimize delivery through examination of different doses or formulations, combine the natural product with known treatments that engage the same target, or study impact in more responsive target populations. The NOFO will not support efficacy or effectiveness trials.
Applications undergo rigorous two-stage peer review with evaluation based on scientific merit, innovation, significance, experimental design, investigator competency, available resources, budget necessity, program relevance, and human or animal subject safeguards. Award timelines average six to ten months from application to notice of award.
Assistance Listing 93.213 (Research and Training in Complementary and Integrative Health).
Synopsis
This Notice of Funding Opportunity (NOFO) encourages applications for investigator-initiated, early phase, clinical trials of natural products (i.e., botanicals, dietary supplements, and probiotics), which have a strong scientific premise to justify further clinical testing. For this NOFO, natural products include promising nutritional regimens that standardize the amount of a specific naturally occurring nutritional compound (e.g., omega-3 fatty acids, anthocyanidins, or polyphenols) and have compelling preliminary evidence. Under this NOFO, trials must be designed so that results, whether positive or negative, will provide information of high scientific utility and will support decisions about further development or testing of the natural product. This NOFO will provide up to 3 years support for studies to replicate the impact of the natural product on target engagement when used by humans, and assess whether there is an association between the degree of the impact on target engagement and functional or clinical outcomes in a patient population. Applications are encouraged to design studies to determine how to optimize the impact of the natural product on target engagement by optimizing the delivery of the natural product through examination of different doses or formulations. In addition, applications can be designed to combine the natural product with another treatment approach that is known to engage the same target; or study the impact of the natural product in a target population that is more responsive. Clinical trials submitted under this NOFO are expected to be hypothesis based, milestone-driven, and directly related to the research priorities and mission of NCCIH. This R33 funding mechanism is intended to accelerate the translation of emerging basic science findings about natural products into early-stage clinical testing to determine whether continued clinical research is warranted. This NOFO will not support efficacy or effectiveness trials, nor will
Eligibility
Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Files
| File | Type | Posted |
|---|---|---|
| PAR-25-270-Full-Announcement.html | HTML file | |
| PKG00289347.pdf |
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